STERiLANCE SteriHeel Plus Heel Incision Safety Lancet

GUDID 06945630125522

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use
Primary Device ID06945630125522
NIH Device Record Key23ba6b69-1456-4a9d-99c7-c3a8256d787d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERiLANCE SteriHeel Plus Heel Incision Safety Lancet
Version Model Number30-106514
Company DUNS554434897
Company NameSterilance Medical (Suzhou) Inc.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106945630125522 [Unit of Use]
GS116945630125529 [Primary]
GS136945630125523 [Package]
Contains: 16945630125529
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-17
Device Publish Date2024-04-09

On-Brand Devices [STERiLANCE SteriHeel Plus Heel Incision Safety Lancet]

06945630110290Sterilance SteriHeel Plus Heel Incision Safety Lancet,50Lancets/box,0.65*1.40mm.
06945630110283Sterilance SteriHeel Plus Heel Incision Safety Lancet,50Lancets/box,0.85*1.75mm.
3694563011501230-101428
3694563011500530-108575
3694563011499230-101025
0694563012552230-106514

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